UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
Title of the study (Brief title)	Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influences of hypoglycemic effect and body weight in patients with poorly controlled type 2 diabetes whereas undergoing DPP-4 inhibitor treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c from baseline to 24 weeks
Key secondary outcomes	Change in following items from baseline to 12 and 24 weeks 1) HbA1c (Except for 24 week), GA 2) Body weight 3) Fasting plasma glucose 4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide 5) Waist circumference (Except for 12 week) 6) Blood pressure and heart rate 7) Uric acid 8) Serum cystatin C (Except for 12 week) 9) Serum lipids (TC, LDL-C, HDL-C, and TG) 10) RLP-C (Remnant like particles cholesterol) (Except for 12 week) 11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week) 12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 24 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Aged 20 to 80 years at providing consent 2) Poorly glycemic controlled patients nevertheless who undergoes DPP-4 inhibitors at least 12 weeks 3) HbA1c >= 6.5 and < 9.5% 4) BMI >= 22 kg/m2 5) Received informed consent
Key exclusion criteria	1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) With severe hepatic dysfunction (Over grade 3 in classification criteria for severity of adverse drug reactions) 5) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 6) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 7) Is receiving SGLT-2 inhibitors, GLP-1 antagonists, or insulin therapy at consent 8) Is nursing or pregnant or planned to become pregnant 9) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 10) Considered as inadequate by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Kenji Furukawa
Organization	Japan Community Health care Organization Kanazawa Hospital
Division name	internal
Address	Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan
TEL	076-252-2200
Email	kenjif-knz@umin.ac.jp

Public contact
Name of contact person	Kenji Furukawa
Organization	Japan Community Health care Organization Kanazawa Hospital
Division name	internal
Address	Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan
TEL	076-252-2200
Homepage URL
Email	kenjif-knz@umin.ac.jp

Sponsor
Institute	Japan Community Health care Organization Kanazawa Hospital
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 10 Day
Anticipated trial start date	2014 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 07 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017196